BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    AS3000 OPERATIVE DENTAL UNIT (DELIVERY SYSTEM)

    K Number: K931204 · Decision Jul 8, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    111
    Registration Numbers
    111
    Same Product Code
    283
    Applicant Total
    7
    Review Days
    121

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    AS3000 OPERATIVE DENTAL UNIT (DELIVERY SYSTEM)
    K Number
    K931204
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Den-Tal-Ez Mfg Co., Inc.
    Date Received
    March 9, 1993
    Decision Date
    July 8, 1993
    Product Code
    EIA
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    EIA Unit, Operative Dental

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (EIA), ordered by most recent decision date.

    Midmark Dental Delivery System

    FDA 510(k)
    FDA Class 1 ·Dental

    K5 Cart, K5 Mount, K5 Swing

    FDA 510(k)
    FDA Class 1 ·Dental

    Integral Dental Unit

    FDA 510(k)
    FDA Class 1 ·Dental

    Integral Dental Units

    FDA 510(k)
    FDA Class 1 ·Dental

    Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus

    FDA 510(k)
    FDA Class 1 ·Dental

    BDC Dental Unit

    FDA 510(k)
    FDA Class 1 ·Dental
    View all

    Other Clearances by Den-Tal-Ez Mfg Co., Inc.

    K Number Device Name
    K925629 ACCESSORY TO IMPROVED DENTAL OPERATING LIGHT
    K932824 EVACUATOR, ORAL CAVITY
    K920017 IMPROVED DENTAL OPERATING LIGHT
    K920016 IMPROVED DENTAL CHAIR
    K874294 AUTOCHUCK ATTACHMENT
    K780469 PANORAMIC X-RAY, DENTAL